On January 4, 2013, FDA proposed the two new regulations implementing the FDA Food Safety Modernization Act (“FSMA”) that are aimed at preventing foodborne illness. The first proposed rule, “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventative Controls for Human Food,” would revise FDA’s CGMP regulations. It would require foreign and domestic food […]
Walk into any mainstream pet store and it is evident that the pet supplement industry is booming. Pet store shelves are packed with animal counterparts to human supplements, such as joint health supplements for cats and dogs. Because of the prevalence of such products, one would never guess that FDA does not recognize dietary supplements […]
Individuals wanting to add a new substance to a conventional food have two options for achieving regulatory compliance. They can either submit a food additive petition to FDA or notify FDA of their determination that the substance is generally recognized as safe (“GRAS”). Under FDA’s food additive regulations, food additives require premarket approval. A “food […]
FDA recommends that dietary supplement manufacturers and distributors voluntarily consult with it concerning the safety of supplements containing high amounts of new dietary ingredients (“NDIs”) that are approved direct food additives or GRAS. An NDI notification must be submitted to FDA at least 75 days before selling a dietary supplement if the dietary supplement contains […]
By Jonathan W. Emord Under the Budget Control Act of 2011, Congress must either agree to spending cuts or a 7.8% across-the-board cut will be imposed on all federal agencies. With the White House and Congressional Republicans at an impasse, those automatic cuts appear likely. For the FDA, that means a reduction in about $68 […]
The FDA and FTC intend to require randomized clinical trials (RCTs) in support of promotional claims for dietary supplements and dietary ingredients. That much is clear. The FTC took that position in the recent POM Wonderful case, and the FDA memorialized that position in its Evidence Based Review System (EBRS). In practice, the FDA will […]
During the Bush Administration, FDA had an unwritten and informal enforcement policy that allowed a website selling dietary supplements to link to scientific literature discussing nutrients in those supplements and diseases, provided that the page containing the scientific literature was at least “two clicks” away from product pages in question. That Bush era policy appears […]
Today, FDA published a notice in the Federal Register informing the public that it is requesting comments and information on conducting a risk assessment to establish regulatory thresholds for major food allergens. 77 Fed. Reg. 74485 (Dec. 14, 2012). Comments must be submitted by February 12, 2013. The Food Allergen Labeling and Consumer Protection Act […]
By Jonathan W. Emord Emord Blog at Emord.com In the FDA Modernization Act of 1997 Congress enacted an amendment that would permit health claims to appear on the labels of foods and dietary supplements if those claims were an accurate representation of an authoritative statement made by a scientific body of the United States […]
The U.S. District Court for the District of Columbia previously held that an individual’s own cultured stem cells constituted both a drug under the Food, Drug, and Cosmetic Act (“FDCA”) and a biological product under the Public Health Service Act (“PHSA”) subject to FDA regulation. U.S. v. Regenerative Sciences, LLC, 2012 WL 2989988 at *6 […]
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